BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSEMBLY, 9300XSP L/S W/AWOS T

    MDR report key: 3374708 · Received September 17, 2013

    Report

    Report Number
    1222895-2013-00021
    Event Type
    Injury
    Date Received
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K864385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS POSSIBLE PT BURN. ON (B)(6) 2013 CUSTOMER REPORTS SURGEON WAS PERFORMING A RIGID PROCTOSCOPY AND TRANS-ANAL EXCISION OF POLYP. TOTAL PROCEDURE TIME WAS 28 MINS AND BURN SEEN WHEN THE DEVICE WAS REMOVED. THE CONNECTION OF THE LIGHT SOURCE TO THE SCOPE BURNED THE PT. IN ORDER TO INSERT THE DEVICE TO THE NECESSARY DEPTH THE CONNECTION WAS UP AGAINST THE PT'S PERINEUM. CHARACTERISTICS OF INJURY, PARTIAL THICKNESS PERIANAL BURN APPROX 1X1 CM IN THE LEFT PERIANAL SKIN. SILVADENE APPLIED ALONG WITH STERILE DRESSINGS. ANTICIPATE AREA TO HEAL. PROCEDURE WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467736 ASSEMBLY, 9300XSP L/S W/AWOS T 300W LS FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR